# K062819: Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Dec 4, 2006 after 75 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854886 (1986). 18 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021684: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002). Our reading of the summary gave K021864, FDA’s number for Primagard Nonsterile Femoral Angiography Drapes (Models… (Primeline Medical Products, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Modified Plate designs for use with the Bioplate® Rigid Fixation…”.
- K992330: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1999) Summary page 1.
- K980983: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1998) Summary page 1.
- K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1997) Summary page 1.
- K953273: Bioplate Rigid Fixation Bone Plating System, Biomedics (1995) Summary page 2.
- K943071: The Titanium Fixation System, Biomedics (1995) Summary page 2.
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 2.
- K912932: Synthes Maxillofacial Titanium Micro Set, Synthes (Usa) (1991) Summary page 2.

## Most influential descendants
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K121606: Resorb-X G (2013), 0 descendants of its own
- K101835: Medpor Fixation System-Cranial, Models 80080, 80079 (2010), 0 descendants of its own

## Indications for use
The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K062819
Methodology: https://510kreport.com/methodology